NCT02642562

Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN

Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,160 (estimated)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.

Detailed description

Chronic heart failure (CHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting symptoms of shortness of breath and fatigue. Hospitalisation for CHF is common and life expectancy reduced. Many patients with CHF have a deficiency of iron (low iron levels or cannot use iron properly), and this is associated with poorer outcomes. Some small research studies have suggested that giving patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with CHF in the long term and whether it improves life expectancy and keeps them out of hospital. This study will help us answer these key questions. This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections. The study will take place in about 70 secondary care sites (hospitals) across the UK. Participants will be recruited over a period of about five years and will be followed up for a minimum of three months (average duration of about four years per participant). After the initial visits, participants will be seen every four months.

Conditions

• Chronic Heart Failure
• Iron Deficiency
• Left Ventricular Systolic Dysfunction

Interventions

Type	Name	Description
DRUG	Ferric Derisomaltose

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2015-12-30
• Last updated: 2022-10-28

Locations

72 sites across 1 country: United Kingdom